Topical neurological stimulation

ABSTRACT

A topical nerve stimulator patch and system are provided comprising a dermal patch; an electrical signal generator associated with the patch; a signal receiver to activate the electrical signal generator; a power source for the electrical signal generator associated with the patch; an electrical signal activation device; and a nerve feedback sensor.

CLAIM OF PRIORITY

This application claims priority to and the benefit of the filing dateof PCT application PCT/US2014/040240 filed on May 30, 2014, and U.S.provisional patent application U.S. Ser. No. 61/828,981 filed on May 30,2013, and incorporates that application in its entirety herein.

COPYRIGHT NOTICE

© 2013 and 2014 GRAHAM CREASEY, MD, & HOO-MIN TOONG, PhD. This patentdocument contains material that is subject to copyright protection. Thecopyright owner has no objection to the facsimile reproduction by anyoneof the patent document or the patent disclosure, as it appears in thePatent and Trademark Office patent file or records, but otherwisereserves all copyright rights whatsoever. 37 CFR § 1.71(d), (e).

TECHNICAL FIELD

This invention pertains to the activation of nerves by topicalstimulators to control or influence muscles, tissues, organs, orsensation, including pain, in humans and mammals.

BACKGROUND

Nerve disorders may result in loss of control of muscle and other bodyfunctions, loss of sensation, or pain. Surgical procedures andmedications sometimes treat these disorders but have limitations. Thisinvention pertains to a system for offering other options for treatmentand improvement of function.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a depiction of a neuron activating a muscle by electricalimpulse.

FIG. 2 is a representation of the electrical potential activation timeof an electrical impulse in a nerve.

FIG. 3 is a cross section of a penis.

FIG. 4 is an illustration of a Topical Nerve Stimulator/Sensor (TNSS)component configuration including a system on a chip (SOC).

FIG. 5 is an illustration of the upper side of a Smart Band Aid™ (SBA)implementation of a TNSS showing location of battery, which may be ofvarious types.

FIG. 6 is a an illustration of the lower side of the SBA of FIG. 5.

FIG. 7 is TNSS components incorporated into a SBA.

FIG. 8 is examples of optional neural stimulator and sensor chip setsincorporated into a SBA.

FIG. 9 is examples of optional electrode configurations for a SBA.

FIG. 10 is an example of the use of TNSS with a Control Unit as aSystem, in a population of Systems and software applications.

FIG. 11 shows a method for forming and steering a beam by the user of aplurality of radiators.

FIG. 12 is an exemplary beam forming and steering mechanism.

FIG. 13 illustrates exemplary Control Units for activating a nervestimulation device.

FIG. 14 are exemplary software platforms for communicating between theControl Units and the TNSS, gathering data, networking with other TNSSs,and external communications.

FIG. 15 represents TNSS applications for patients with spinal cordinjury.

FIG. 16 shows an example TNSS system.

FIG. 17 shows communications among the components of the TNSS system ofFIG. 16 and a user.

FIG. 18 shows an example electrode configuration for electric fieldsteering and sensing.

FIG. 19 shows an example of stimulating and sensing patterns of signalsin a volume of tissue.

DETAILED DESCRIPTION

A method for electrical, mechanical, chemical and/or optical interactionwith a human or mammal nervous system to stimulate and/or record bodyfunctions using small electronic devices attached to the skin andcapable of being wirelessly linked to and controlled by a cellphone,activator or computer network.

The body is controlled by a chemical system and a nervous system. Nervesand muscles produce and respond to electrical voltages and currents.Electrical stimulation of these tissues can restore movement or feelingwhen these have been lost, or can modify the behavior of the nervoussystem, a process known as neuro modulation. Recording of the electricalactivity of nerves and muscles is widely used for diagnosis, as in theelectrocardiogram, electromyogram, electroencephalogram, etc. Electricalstimulation and recording require electrical interfaces for input andoutput of information. Electrical interfaces between tissues andelectronic systems are usually one of three types:

a. Devices implanted surgically into the body, such as pacemakers. Theseare being developed for a variety of functions, such as restoringmovement to paralyzed muscles or restoring hearing, and can potentiallybe applied to any nerve or muscle. These are typically specialized andsomewhat expensive devices.

b. Devices inserted temporarily into the tissues, such as needles orcatheters, connected to other equipment outside the body. Health carepractitioners use these devices for diagnosis or short-term treatment.

c. Devices that record voltage from the surface of the skin fordiagnosis and data collection, or apply electrical stimuli to thesurface of the skin using adhesive patches connected to a stimulator.Portable battery-powered stimulators have typically been simple devicesoperated by a patient, for example for pain relief. Their use has beenlimited by;

i. The inconvenience of chronically managing wires, patches andstimulator, particularly if there are interfaces to more than one site,and

ii. The difficulty for patients to control a variety of stimulusparameters such as amplitude, frequency, pulse width, duty cycle, etc.

Nerves can also be stimulated mechanically to produce sensation orprovoke or alter reflexes; this is the basis of touch sensation andtactile feedback. Nerves can also be affected chemically by medicationsdelivered locally or systemically and sometimes targeted to particularnerves on the basis of location or chemical type. Nerves can also bestimulated or inhibited optically if they have had genes inserted tomake them light sensitive like some of the nerves in the eye. Theactions of nerves also produce electrical, mechanical and chemicalchanges that can be sensed.

The topical nerve stimulator/sensor (TNSS) is a device to stimulatenerves and sense the actions of the body that can be placed on the skinof a human or mammal to act on and respond to a nerve, muscle or tissue.One implementation of the TNSS is the Smart Band Aid™ (SBA). A system,incorporating a SBA, controls neuro modulation and neuro stimulationactivities. It consists of one or more controllers or Control Units, oneor more TNSS modules, software that resides in Control Units and TNSSmodules, wireless communication between these components, and a datamanaging platform. The controller hosts software that will control thefunctions of the TNSS. The controller takes inputs from the TNSS of dataor image data for analysis by said software, The controller provides aphysical user interface for display to and recording from the user, suchas activating or disabling the TNSS, logging of data and usagestatistics, generating reporting data. Finally, the controller providescommunications with other Controllers or the Internet cloud.

The controller communicates with the neurostim module, also called TNSSmodule or SBA, and also communicates with the user. In at least oneexample, both of these communications can go in both directions, so eachset of communications is a control loop. Optionally, there may also be acontrol loop directly between the TNSS module and the body. So thesystem optionally may be a hierarchical control system with at leastfour control loops. One loop is between the TNSS and the body; anotherloop is between the TNSS and the controller; another loop is between thecontroller and the user; and another loop is between the controller andother users via the cloud, which may be located in the TNSS, thecontroller or the cloud, has several functions including: (1) sendingactivation or disablement signals between the controller and the TNSSvia a local network such as Bluetooth; (2) driving the user interface,as when the controller receives commands from the user and providesvisual, auditory or tactile feedback to the user; (3) analyzing TNSSdata, as well as other feedback data such as from the user, within theTNSS, and/or the controller and/or or the cloud; (4) making decisionsabout the appropriate treatment; (5) system diagnostics for operationalcorrectness; and (6) communications with other controllers or users viathe Internet cloud for data transmission or exchange, or to interactwith apps residing in the Internet cloud.

The control loop is closed. This is as a result of having bothstimulating and sensing. The sensing provides information about theeffects of stimulation, allowing the stimulation to be adjusted to adesired level or improved automatically.

Typically, stimulation will be applied. Sensing will be used to measurethe effects of stimulation. The measurements sensed will be used tospecify the next stimulation. This process can be repeated indefinitelywith various durations of each part. For example: rapid cycling throughthe process (a-b-c-a-b-c-a-b-c); prolonged stimulation, occasionalsensing (aaaa-b-c-aaaa-b-c-aaaa-b-c); or prolonged sensing, occasionalstimulation (a-bbbb-c-a-bbbb-c-a-bbbb). The process may also start withsensing, and when an event in the body is detected this information isused to specify stimulation to treat or correct the event, for example,(bbbbbbbbb-c-a-bbbbbbbb-c-a-bbbbbbbbb). Other patterns are possible andcontemplated within the scope of the application.

The same components can be used for stimulating and sensing alternately,by switching their connection between the stimulating circuits and thesensing circuits. The switching can be done by standard electroniccomponents. In the case of electrical stimulating and sensing, the sameelectrodes can be used for both. An electronic switch is used to connectstimulating circuits to the electrodes and electric stimulation isapplied to the tissues. Then the electronic switch disconnects thestimulating circuits from the electrodes and connects the sensingcircuits to the electrodes and electrical signals from the tissues arerecorded.

In the case of acoustic stimulating and sensing, the same ultrasonictransducers can be used for both (as in ultrasound imaging or radar). Anelectronic switch is used to connect circuits to the transducers to sendacoustic signals (sound waves) into the tissues. Then the electronicswitch disconnects these circuits from the transducers and connectsother circuits to the transducers (to listen for reflected sound waves)and these acoustic signals from the tissues are recorded.

Other modalities of stimulation and sensing may be used (e.g. light,magnetic fields, etc) The closed loop control may be implementedautonomously by an individual TNSS or by multiple TNSS modules operatingin a system such as that shown below in FIG. 16. Sensing might becarried out by some TNSSs and stimulation by others.

Stimulators are protocol controlled initiators of electricalstimulation, where such protocol may reside in either the TNSS and/orthe controller and/or the cloud. Stimulators interact with associatedsensors or activators, such as electrodes or MEMS devices.

The protocol, which may be located in the TNSS, the controller or thecloud, has several functions including:

(1) Sending activation or disablement signals between the controller andthe TNSS via a local network such as Bluetooth. The protocol sends asignal by Bluetooth radio waves from the smartphone to the TNSS moduleon the skin, telling it to start or stop stimulating or sensing. Otherwireless communication types are possible.

(2) Driving the user interface, as when the controller receives commandsfrom the user and provides visual, auditory or tactile feedback to theuser. The protocol receives a command from the user when the usertouches an icon on the smartphone screen, and provides feedback to theuser by displaying information on the smartphone screen, or causing thesmartphone to beep or buzz.

(3) Analyzing TNSS data, as well as other feedback data such as from theuser, within the TNSS, and/or the controller and/or or the cloud. Theprotocol analyzes data sensed by the TNSS, such as the position of amuscle, and data from the user such as the user's desires as expressedwhen the user touches an icon on the smartphone; this analysis can bedone in the TNSS, in the smartphone, and/or in the cloud.

(4) Making decisions about the appropriate treatment. The protocol usesthe data it analyzes to decide what stimulation to apply.

(5) System diagnostics for operational correctness. The protocol checksthat the TNSS system is operating correctly.

(6) Communications with other controllers or users via the Internetcloud for data transmission or exchange, or to interact with appsresiding in the Internet cloud. The protocol communicates with othersmartphones or people via the internet wirelessly; this may includesending data over the internet, or using computer programs that areoperating elsewhere on the internet.

A neurological control system, method and apparatus are configured in anecosystem or modular platform that uses potentially disposable topicaldevices to provide interfaces between electronic computing systems andneural systems. These interfaces may be direct electrical connectionsvia electrodes or may be indirect via transducers (sensors andactuators). It may have the following elements in variousconfigurations: electrodes for sensing or activating electrical eventsin the body; actuators of various modalities; sensors of variousmodalities; wireless networking; and protocol applications, e.g. fordata processing, recording, control systems. These components areintegrated within the disposable topical device. This integration allowsthe topical device to function autonomously. It also allows the topicaldevice along with a remote control unit (communicating wirelessly via anantenna, transmitter and receiver) to function autonomously.

Referring to FIG. 1, nerve cells are normally electrically polarizedwith the interior of the nerve being at an electric potential 70 mVnegative relative to the exterior of the cell. Application of a suitableelectric voltage to a nerve cell (raising the resting potential of thecell from −70 mV to above the firing threshold of −55 mV) can initiate asequence of events in which this polarization is temporarily reversed inone region of the cell membrane and the change in polarization spreadsalong the length of the cell to influence other cells at a distance,e.g. to communicate with other nerve cells or to cause or prevent musclecontraction.

Referring to FIG. 2, graphically represents a nerve impulse from a pointof stimulation resulting in a wave of depolarization followed by arepolarization that travels along the membrane of a neuron during themeasured period. This spreading action potential is a nerve impulse. Itis this phenomenon that allows for external electrical nervestimulation.

Referring to FIG. 3, the dorsal genital nerve on the back of the penisor clitoris just under the skin is a purely sensory nerve that isinvolved in normal inhibition of the activity of the bladder duringsexual activity, and electrical stimulation of this nerve has been shownto reduce the symptoms of the Over Active Bladder. Stimulation of theunderside of the penis may cause sexual arousal, erection, ejaculationand orgasm.

A Topical nerve stimulator/sensor (TNSS) is used to stimulate thesenerves and is convenient, unobtrusive, self-powered, controlled from asmartphone or other control device. This has the advantage of beingnon-invasive, controlled by consumers themselves, and potentiallydistributed over the counter without a prescription.

Referring to FIG. 4, the TNSS has one or more electronic circuits orchips that perform the functions of: communications with the controller,nerve stimulation via one or more electrodes 408 that produce a widerange of electric field(s) according to treatment regimen, one or moreantennae 410 that may also serve as electrodes and communicationpathways, and a wide range of sensors 406 such as, but not limited to,mechanical motion and pressure, temperature, humidity, chemical andpositioning sensors. One arrangement would be to integrate a widevariety of these functions into an SOC, system on chip 400. Within thisis shown a control unit 402 for data processing, communications andstorage and one or more stimulators 404 and sensors 406 that areconnected to electrodes 408. An antenna 410 is incorporated for externalcommunications by the control unit. Also present is an internal powersupply 412, which may be, for example, a battery. An external powersupply is another variation of the chip configuration. It may benecessary to include more than one chip to accommodate a wide range ofvoltages for data processing and stimulation. Electronic circuits andchips will communicate with each other via conductive tracks within thedevice capable of transferring data and/or power.

In one or more examples, a Smart Band Aid™ incorporating a battery andelectronic circuit and electrodes in the form of adhesive conductivepads may be applied to the skin, and electrical stimuli is passed fromthe adhesive pads into the tissues. Stimuli may typically be trains ofvoltage-regulated square waves at frequencies between 15 and 50 Hz withcurrents between 20 and 100 mA. The trains of stimuli are controlledfrom a smartphone operated by the user. Stimuli may be either initiatedby the user when desired, or programmed according to a timed schedule,or initiated in response to an event detected by a sensor on the SmartBand Aid™ or elsewhere. Another implementation for males may be a TNSSincorporated in a ring that locates a stimulator conductively toselected nerves in a penis to be stimulated.

Referring to FIG. 5, limited lifetime battery sources will be employedas internal power supply 412, to power the TNSS deployed in thisillustration as a Smart Band Aid™. These may take the form of LithiumIon technology or traditional non-toxic MnO2 technologies. FIG. 5illustrates different battery options such as a printable ManganeseOxide battery 516 and a button battery 518. A TNSS of different shapesmay require different battery packaging.

FIG. 6 shows an alternate arrangement of these components where thebatteries 616-618 are positioned on the bottom side of the SBA betweenthe electrodes 610 and 620. In this example, battery 616 is a lithiumion battery, battery 617 is a MnO2 battery and battery 618 is a buttonbattery. Other types of batteries and other battery configurations arepossible within the scope of this application in other examples.

Aside from the Controller, the Smart Band Aid™ Packaging Platformconsists of an assembly of an adhesive patch capable of being applied tothe skin and containing the TNSS Electronics, protocol, and powerdescribed above.

Referring to FIG. 7 is a TNSS deployed as a Smart Band Aid™ 414. TheSmart Band Aid™ has a substrate with adhesive on a side for adherence toskin, the SOC 400 previously described in FIG. 4, or electronic package,and one or more electrodes 408 disposed between the dermis and theadhesive surface. The electrodes provide electrical stimuli through thedermis to nerves and other tissue and in turn may collect electricalsignals from the body, such as the electrical signals produced bymuscles when they contract (the electromyogram) to provide data aboutbody functions such as muscle actions.

Referring to FIG. 8, different chips may be employed to designrequirements. Shown are sample chips for packaging in a TNSS in thisinstance deployed as a SBA. For example, neural stimulator 800, sensor802, processor/communications 804 are represented. The chips can bepackaged separately on a substrate, including a flexible material, or asa system-on-chip (SOC) 400. The chip connections and electronics packageare not shown but are known in the art.

Referring to FIG. 9 SBAs with variations on arrangements of electrodesare shown. Each electrode may consist of a plurality of conductivecontacts that give the electrode abilities to adjust the depth,directionality, and spatial distribution of the applied electric field.For all the example electrode configurations shown, 901-904, the depthof the electrical stimulation can be controlled by the voltage and powerapplied to the electrode contacts. Electric current can be applied tovarious electrode contacts at opposite end of the SBA, or within aplurality of electrode contacts on a single end of the SBA. The phaserelationship of the signals applied to the electrode contacts can varythe directionality of the electric field. For all configurations ofelectrodes, the applied signals can vary over time and spatialdimensions. The configuration on the left, 901, shows a plurality ofconcentric electrode contacts at either end of the SBA. Thisconfiguration can be used to apply an electric stimulating field atvarious tissue depths by varying the power introduced to the electrodecontacts. The next configuration, 902, shows electrodes 404 that arearranged in a plurality of parallel strips of electrical contacts. Thisallows the electric field to be oriented perpendicular or parallel tothe SBA. The next configuration, 903, shows an example matrix ofelectrode contacts where the applied signal can generate a stimulatingfield between any two or more electrode contacts at either end of theSBA, or between two or more electrode contacts within a single matrix atone end of the SBA. Finally, the next configuration on the far right,904, also shows electrodes that are arranged in a plurality of parallelstrips of electrical contacts. As with the second configuration, thisallows the electric field to be oriented perpendicular or parallel tothe SBA. There may be many other arrangements of electrodes andcontacts.

One or more TNSSs with one or more Controllers form a System. Systemscan communicate and interact with each other and with distributedvirtualized processing and storage services. This enables the gathering,exchange, and analysis of data among populations of systems for medicaland non-medical applications.

Referring to FIG. 10, a system is shown with two TNSS units 1006, withone on the wrist, one on the leg, communicating with its controller, asmartphone 1000 or other control device. The TNSS units can be bothsensing and stimulating and can act independently and also work togetherin a Body Area Network (BAN). Systems communicate with each other over acommunication bridge or network such as a cellular network. Systems alsocommunicate with applications running in a distributed virtualizedprocessing and storage environment generally via the Internet 1002. Thepurpose for communications with the distributed virtualized processingand storage environment is to communicate large amounts of user data foranalysis and networking with other third parties such as hospitals,doctors, insurance companies, researchers, and others. There areapplications that gather, exchange, and analyze data from multipleSystems 1004. Third party application developers can access TNSS systemsand their data to deliver a wide range of applications. Theseapplications can return data or control signals to the individualwearing the TNSS unit 1006. These applications can also send data orcontrol signals to other members of the population who employ systems1008. This may represent an individual's data, aggregated data from apopulation of users, data analyses, or supplementary data from othersources.

Referring to FIG. 11, shown is an example of an electrode array toaffect beam forming and beam steering. Beam forming and steering allowsa more selective application of stimulation energy by a TNSS to nervesand tissue. Beam steering also provides the opportunity for lower powerfor stimulation of cells including nerves by applying the stimulatingmechanism directionally to a target. In the use of an electrical beamlower power demand lengthens battery life and allows for use of lowpower chip sets. Beam steering may be accomplished in multiple ways forinstance by magnetic fields and formed gates. FIG. 11 shows a method forforming and steering a beam by the use of a plurality of radiators 1102which are activated out of phase with each other by a plurality of phaseshifters 1103 that are supplied power from a common source 1104. Becausethe radiated signals are out of phase they produce an interferencepattern 1105 that results in the beam being formed and steered invarying controlled directions 1106. Electromagnetic radiation like lightshows some properties of waves and can be focused on certain locations.This provides the opportunity to stimulate tissues such as nervesselectively. It also provides the opportunity to focus the transmissionof energy and data on certain objects, including topical or implantedelectronic devices, thereby not only improving the selectivity ofactivating or controlling those objects but also reducing the overallpower required to operate them.

FIG. 12 is another example of a gating structure 1200 used for beamshaping and steering 1202. The gating structure 1200 shows an example ofan interlocked pair of electrodes that can be used for simple beamforming through the application of time-varying voltages. The steering1202 shows a generic picture of the main field lobes and how such beamsteering works in this example. FIG. 12 is illustrative of a possibleexample that may be used.

The human and mammal body is an anisotropic medium with multiple layersof tissue of varying electrical properties. Steering of an electricfield may be accomplished using multiple electrodes, or multiple SBAs,using the human or mammal body as an anisotropic volume conductor.Electric field steering will discussed below with reference to FIGS. 18and 19.

Referring to FIG. 13, the controller is an electronics platform that isa smartphone 1300, tablet 1302, personal computer 1304, or dedicatedmodule 1306 that hosts wireless communications capabilities, such asNear Field Communications, Bluetooth, or Wi-Fi technologies as enabledby the current set of communications chips, e.g. Broadcom BCM4334, TIWiLink 8 and others, and a wide range of protocol apps that cancommunicate with the TNSSs. There may be more than one controller,acting together. This may occur, for example, if the user has both asmartphone control app running, and a key fob controller in his/herpocket/purse.

TNSS protocol performs the functions of communications with thecontroller including transmitting and receiving of control and datasignals, activation and control of the neural stimulation, datagathering from on board sensors, communications and coordination withother TNSSs, and data analysis. Typically the TNSS may receive commandsfrom the controller, generate stimuli and apply these to the tissues,sense signals from the tissues, and transmit these to the controller. Itmay also analyze the signals sensed and use this information to modifythe stimulation applied. In addition to communicating with thecontroller it may also communicate with other TNSSs using electrical orradio signals via a body area network.

Referring to FIG. 14, controller protocol executed and/or displayed on asmartphone 1400, tablet 1402 or other computing platform or mobiledevice, will perform the functions of communications with TNSS modulesincluding transmitting and receiving of control and data signals,activation and control of the neuro modulation regimens, data gatheringfrom on board sensors, communications and coordination with othercontrollers, and data analysis. In some cases local control of the neuromodulation regimens may be conducted by controller protocol withoutcommunications with the user.

FIG. 15 shows potential applications of electrical stimulation andsensing for the body, particularly for users who may suffer fromparalysis or loss of sensation or altered reflexes such as spasticity ortremor due to neurological disorders and their complications, as well asusers suffering from incontinence, pain, immobility and aging. Differentexample medical uses of the present system are discussed below.

FIG. 16 shows the components of one example of a typical TNSS system1600. TNSS devices 1610 are responsible for stimulation of nerves andfor receiving data in the form of electrical, acoustic, imaging,chemical and other signals which then can be processed locally in theTNSS or passed to the Control Unit 1620. TNSS devices 1610 are alsoresponsible for analysis and action. The TNSS device 1610 may contain aplurality of electrodes for stimulation and for sensing. The sameelectrodes may be used for both functions, but this is not required. TheTNSS device 1610 may contain an imaging device, such as an ultrasonictransducer to create acoustic images of the structure beneath theelectrodes or elsewhere in the body that may be affected by the neuralstimulation.

In this example TNSS system, most of the data gathering and analysis isperformed in the Control Unit 1620. The Control Unit 1620 may be acellular telephone or a dedicated hardware device. The Control Unit 1620runs an app that controls the local functions of the TNSS System 1600.The protocol app also communicates via the Internet or wireless networks1630 with other TNSS systems and/or with 3rd party softwareapplications.

FIG. 17 shows the communications among the components of the TNSS system1600 and the user. In this example, TNSS 1610 is capable of applyingstimuli to nerves 1640 to produce action potentials in the nerves 1640to produce actions in muscles 1670 or other organs such as the brain1650. These actions may be sensed by the TNSS 1610, which may act on theinformation to modify the stimulation it provides. This closed loopconstitutes the first level of the system 1600 in this example.

The TNSS 1610 may also be caused to operate by signals received from aControl Unit 1620 such as a cellphone, laptop, key fob, tablet, or otherhandheld device and may transmit information that it senses back to theControl Unit 1620. This constitutes the second level of the system 1600in this example.

The Control Unit 1620 is caused to operate by commands from a user, whoalso receives information from the Control Unit 1620. The user may alsoreceive information about actions of the body via natural senses such asvision or touch via sensory nerves and the spinal cord, and may in somecases cause actions in the body via natural pathways through the spinalcord to the muscles.

The Control Unit 1620 may also communicate information to other users,experts, or application programs via the Internet 1630, and receiveinformation from them via the Internet 1630.

The user may choose to initiate or modify these processes, sometimesusing protocol applications residing in the TNSS 1610, the Control Unit1620, the Internet 1630, or wireless networks. This software may assistthe user, for example by processing the stimulation to be delivered tothe body to render it more selective or effective for the user, and/orby processing and displaying data received from the body or from theInternet 1630 or wireless networks to make it more intelligible oruseful to the user.

FIG. 18 shows an example electrode configuration 1800 for Electric FieldSteering. The application of an appropriate electric field to the bodycan cause a nerve to produce an electrical pulse known as an actionpotential. The shape of the electric field is influenced by theelectrical properties of the different tissue through which it passesand the size, number and position of the electrodes used to apply it.The electrodes can therefore be designed to shape or steer or focus theelectric field on some nerves more than on others, thereby providingmore selective stimulation.

An example 10×10 matrix of electrical contacts 1860 is shown. By varyingthe pattern of electrical contacts 1860 employed to cause an electricfield 1820 to form and by time varying the applied electrical power tothis pattern of contacts 1860, it is possible to steer the field 1820across different parts of the body, which may include muscle 1870, bone,fat, and other tissue, in three dimensions. This electric field 1820 canactivate specific nerves or nerve bundles 1880 while sensing theelectrical and mechanical actions produced 1890, and thereby enablingthe TNSS to discover more effective or the most effective pattern ofstimulation for producing the desired action.

FIG. 19 shows a example of stimulating and sensing patterns of signalsin a volume of tissue. Electrodes 1910 as part of a cuff arrangement areplaced around limb 1915. The electrodes 1910 are external to a layer ofskin 1916 on limb 1915. Internal components of the limb 1915 includemuscle 1917, bone 1918, nerves 1919, and other tissues. By usingelectric field steering for stimulation, as described with reference toFIG. 18, the electrodes 1910 can activate nerves 1919 selectively. Anarray of sensors (e.g. piezoelectric sensors or micro-electro-mechanicalsensors) in a TNSS can act as a phased array antenna for receivingultrasound signals, to acquire ultrasonic images of body tissues.Electrodes 1910 may act as an array of electrodes sensing voltages atdifferent times and locations on the surface of the body, with softwareprocessing this information to display information about the activity inbody tissues, e.g. which muscles are activated by different patterns ofstimulation.

The SBA's ability to stimulate and collect organic data has multipleapplications including bladder control, reflex incontinence, sexualstimulations, pain control and wound healing among others. Examples ofSBA's application for medical and other uses follow.

Medical Uses

Bladder Management

1) Overactive bladder: When the user feels a sensation of needing toempty the bladder urgently, he or she presses a button on the Controllerto initiate stimulation via a Smart Band Aid™ applied over the dorsalnerve of the penis or clitoris. Activation of this nerve would inhibitthe sensation of needing to empty the bladder urgently, and allow it tobe emptied at a convenient time.

2) Incontinence: A person prone to incontinence of urine because ofunwanted contraction of the bladder uses the SBA to activate the dorsalnerve of the penis or clitoris to inhibit contraction of the bladder andreduce incontinence of urine. The nerve could be activated continuously,or intermittently when the user became aware of the risk ofincontinence, or in response to a sensor indicating the volume orpressure in the bladder.

Erection, ejaculation and orgasm: Stimulation of the nerves on theunderside of the penis by a Smart Band Aid™ (electrical stimulation ormechanical vibration) can cause sexual arousal and might be used toproduce or prolong erection and to produce orgasm and ejaculation.

Pain control: A person suffering from chronic pain from a particularregion of the body applies a Smart Band Aid™ over that region andactivates electrically the nerves conveying the sensation of touch,thereby reducing the sensation of pain from that region. This is basedon the gate theory of pain.

Wound care: A person suffering from a chronic wound or ulcer applies aSmart Band Aid™ over the wound and applies electrical stimulicontinuously to the tissues surrounding the wound to accelerate healingand reduce infection.

Essential tremor: A sensor on a Smart Band Aid™ detects the tremor andtriggers neuro stimulation to the muscles and sensory nerves involved inthe tremor with an appropriate frequency and phase relationship to thetremor. The stimulation frequency would typically be at the samefrequency as the tremor but shifted in phase in order to cancel thetremor or reset the neural control system for hand position.

Reduction of spasticity: Electrical stimulation of peripheral nerves canreduce spasticity for several hours after stimulation. A Smart Band Aid™operated by the patient when desired from a smartphone could providethis stimulation.

Restoration of sensation and sensory feedback: People who lacksensation, for example as a result of diabetes or stroke use a SmartBand Aid™ to sense movement or contact, for example of the foot strikingthe floor, and the SBA provides mechanical or electrical stimulation toanother part of the body where the user has sensation, to improve safetyor function. Mechanical stimulation is provided by the use of acoustictransducers in the SBA such as small vibrators. Applying a Smart BandAid™ to the limb or other assistive device provides sensory feedbackfrom artificial limbs. Sensory feedback can also be used to substituteone sense for another, e.g. touch in place of sight.

Recording of mechanical activity of the body: Sensors in a Smart BandAid™ record position, location and orientation of a person or of bodyparts and transmit this data to a smartphone for the user and/or toother computer networks for safety monitoring, analysis of function andcoordination of stimulation.

Recording of sound from the body or reflections of ultrasound wavesgenerated by a transducer in a Smart Band Aid™ could provide informationabout body structure, e.g. bladder volume for persons unable to feeltheir bladder. Acoustic transducers may be piezoelectric devices or MEMSdevices that transmit and receive the appropriate acoustic frequencies.Acoustic data may be processed to allow imaging of the interior of thebody.

Recording of Electrical Activity of the Body

Electrocardiogram: Recording the electrical activity of the heart iswidely used for diagnosing heart attacks and abnormal rhythms. It issometimes necessary to record this activity for 24 hours or more todetect uncommon rhythms. A Smart Band Aid™ communicating wirelessly witha smartphone or computer network achieves this more simply than presentsystems.

Electromyogram: Recording the electrical activity of muscles is widelyused for diagnosis in neurology and also used for movement analysis.Currently this requires the use of many needles or adhesive pads on thesurface of the skin connected to recording equipment by many wires.Multiple Smart Band Aids™ record the electrical activity of many musclesand transmit this information wirelessly to a smartphone.

Recording of optical information from the body: A Smart Band Aid™incorporating a light source (LED, laser) illuminates tissues and sensesthe characteristics of the reflected light to measure characteristics ofvalue, e.g. oxygenation of the blood, and transmit this to a cellphoneor other computer network.

Recording of chemical information from the body: The levels of chemicalsor drugs in the body or body fluids is monitored continuously by a SmartBand Aid™ sensor and transmitted to other computer networks andappropriate feedback provided to the user or to medical staff. Levels ofchemicals may be measured by optical methods (reflection of light atparticular wavelengths) or by chemical sensors.

Special Populations of Disabled Users

There are many potential applications of electrical stimulation fortherapy and restoration of function. However, few of these have beencommercialized because of the lack of affordable convenient and easilycontrollable stimulation systems. Some applications are shown in theFIG. 15.

Limb Muscle stimulation: Lower limb muscles can be exercised bystimulating them electrically, even if they are paralyzed by stroke orspinal cord injury. This is often combined with the use of a stationaryexercise cycle for stability. Smart Band Aid™ devices could be appliedto the quadriceps muscle of the thigh to stimulate these, extending theknee for cycling, or to other muscles such as those of the calf. Sensorsin the Smart Band Aid™ could trigger stimulation at the appropriate timeduring cycling, using an application on a smartphone, tablet, handheldhardware device such as a key fob, wearable computing device, laptop, ordesktop computer, among other possible devices. Upper limb muscles canbe exercised by stimulating them electrically, even if they areparalyzed by stroke of spinal cord injury. This is often combined withthe use of an arm crank exercise machine for stability. Smart Band Aid™devices are applied to multiple muscles in the upper limb and triggeredby sensors in the Smart Band Aids™ at the appropriate times, using anapplication on a smartphone.

Prevention of osteoporosis: Exercise can prevent osteoporosis andpathological fractures of bones. This is applied using Smart Band Aids™in conjunction with exercise machines such as rowing simulators, evenfor people with paralysis who are particularly prone to osteoporosis.

Prevention of deep vein thrombosis: Electric stimulation of the musclesof the calf can reduce the risk of deep vein thrombosis and potentiallyfatal pulmonary embolus. Electric stimulation of the calf muscles isapplied by a Smart Band Aid™ with stimulation programmed from asmartphone, e.g. during a surgical operation, or on a preset scheduleduring a long plane flight.

Restoration of Function (Functional Electrical Stimulation)

Lower Limb

1) Foot drop: People with stroke often cannot lift their forefoot anddrag their toes on the ground. A Smart Band Aid™ is be applied justbelow the knee over the common peroneal nerve to stimulate the musclesthat lift the forefoot at the appropriate time in the gait cycle,triggered by a sensor in the Smart Band Aid™

2) Standing: People with spinal cord injury or some other paralyses canbe aided to stand by electrical stimulation of the quadriceps muscles oftheir thigh. These muscles are stimulated by Smart Band Aids™ applied tothe front of the thigh and triggered by sensors or buttons operated bythe patient using an application on a smartphone. This may also assistpatients to use lower limb muscles when transferring from a bed to achair or other surface.

3) Walking: Patients with paralysis from spinal cord injury are aided totake simple steps using electrical stimulation of the lower limb musclesand nerves. Stimulation of the sensory nerves in the common peronealnerve below the knee can cause a triple reflex withdrawal, flexing theankle, knee and hip to lift the leg, and then stimulation of thequadriceps can extend the knee to bear weight. The process is thenrepeated on the other leg. Smart Band Aids™ coordinated by anapplication in a smartphone produce these actions.

Upper Limb

1) Hand grasp: People with paralysis from stroke or spinal cord injuryhave simple hand grasp restored by electrical stimulation of the musclesto open or close the hand. This is produced by Smart Band Aids™ appliedto the back and front of the forearm and coordinated by sensors in theSmart Band Aids™ and an application in a smartphone.

2) Reaching: Patients with paralysis from spinal cord injury sometimescannot extend their elbow to reach above the head. Application of aSmart Band Aid™ to the triceps muscle stimulates this muscle to extendthe elbow. This is triggered by a sensor in the Smart Band Aid™detecting arm movements and coordinating it with an application on asmartphone.

Posture: People whose trunk muscles are paralyzed may have difficultymaintaining their posture even in a wheelchair. They may fall forwardunless they wear a seatbelt, and if they lean forward they may be unableto regain upright posture. Electrical stimulation of the muscles of thelower back using a Smart Band Aid™ allows them to maintain and regainupright posture. Sensors in the Smart Band Aid™ trigger this stimulationwhen a change in posture was detected.

Coughing: People whose abdominal muscles are paralyzed cannot produce astrong cough and are at risk for pneumonia. Stimulation of the musclesof the abdominal wall using a Smart Band Aid™ could produce a moreforceful cough and prevent chest infections. The patient using a sensorin a Smart Band Aid™ triggers the stimulation.

Essential Tremor: It has been demonstrated that neuro stimulation canreduce or eliminate the signs of ET. ET may be controlled using a TNSS.A sensor on a Smart Band Aid™ detects the tremor and trigger neurostimulation to the muscles and sensory nerves involved in the tremorwith an appropriate frequency and phase relationship to the tremor. Thestimulation frequency is typically be at the same frequency as thetremor but shifted in phase in order to cancel the tremor or reset theneural control system for hand position.

Non-Medical Applications

Sports Training

Sensing the position and orientation of multiple limb segments is usedto provide visual feedback on a smartphone of, for example, a golfswing, and also mechanical or electrical feedback to the user atparticular times during the swing to show them how to change theiractions. The electromyogram of muscles could also be recorded from oneor many Smart Band Aids™ and used for more detailed analysis.

Gaming

Sensing the position and orientation of arms, legs and the rest of thebody produces a picture of an onscreen player that can interact withother players anywhere on the Internet. Tactile feedback would beprovided to players by actuators in Smart Band Aids on various parts ofthe body to give the sensation of striking a ball, etc.

Motion Capture for Film and Animation

Wireless TNSS capture position, acceleration, and orientation ofmultiple parts of the body. This data may be used for animation of ahuman or mammal and has application for human factor analysis anddesign.

Sample Modes of Operation

A SBA system consists of at least a single Controller and a single SBA.Following application of the SBA to the user's skin, the user controlsit via the Controller's app using Near Field Communications. The appappears on a smartphone screen and can be touch controlled by the user;for ‘key fob’ type Controllers, the SBA is controlled by pressingbuttons on the key fob.

When the user feels the need to activate the SBA s/he presses the “go”button two or more times to prevent false triggering, thus deliveringthe neuro stimulation. The neuro stimulation may be delivered in avariety of patterns of frequency, duration, and strength and maycontinue until a button is pressed by the user or may be delivered for alength of time set in the application.

Sensor capabilities in the TNSS, are enabled to startcollecting/analyzing data and communicating with the controller whenactivated.

The level of functionality in the protocol app, and the protocolembedded in the TNSS, will depend upon the neuro modulation or neurostimulation regimen being employed.

In some cases there will be multiple TNSSs employed for the neuromodulation or neuro stimulation regimen. The basic activation will bethe same for each TNSS.

However, once activated multiple TNSSs will automatically form a networkof neuro modulation/stimulation points with communications enabled withthe controller.

The need for multiple TNSSs arises from the fact that treatment regimensmay need several points of access to be effective.

While illustrative systems and methods as described herein embodyingvarious aspects of the present disclosure are shown, it will beunderstood by those skilled in the art, that the invention is notlimited to these embodiments. Modifications may be made by those skilledin the art, particularly in light of the foregoing teachings. Forexample, each of the elements of the aforementioned embodiments may beutilized alone or in combination or subcombination with elements of theother embodiments. It will also be appreciated and understood thatmodifications may be made without departing from the true spirit andscope of the present disclosure. The description is thus to be regardedas illustrative instead of restrictive on the present invention.

We claim:
 1. A topical nerve stimulator system comprising: a flexibledermis conforming patch defining a surface and formed by a substrate;electrodes positioned on the patch proximal the surface and directlycoupled to the substrate; electronic circuitry embedded in the patchcomprising a system on a chip that is directly coupled to the substrateand comprising: an electrical signal generator configured toelectrically activate the electrodes; a signal receiver in communicationwith the electrical signal generator; an antenna; a transmitter; and areceiver; a remote control device in wireless communication with theelectronic circuitry, the remote control device configured to provide asignal to start stimulation on a user via the electrodes, the signalgenerated in response to the user interacting with the remote controldevice.
 2. The topical nerve stimulator system of claim 1, the surfacefurther comprises adhesive.
 3. The topical nerve stimulator system ofclaim 1, further comprising a feedback sensor on the patch coupled tothe substrate and configured to sense muscle and/or nerve activation andcommunicate data to the remote control device.
 4. The topical nervestimulator system of claim 1, the remote control device is a smartphoneand the signal is generated via a smartphone app.
 5. The topical nervestimulator system of claim 1, the remote control device is a key fobcontroller comprising a button and the signal is generated via apressing of the button.
 6. The topical nerve stimulator system of claim3, the stimulation based on a stimulation pattern that is revised inresponse to the sensed muscle and/or nerve activation.
 7. The topicalnerve stimulator system of claim 1, the electrodes configured tostimulate a mammalian nerve.
 8. The topical nerve stimulator system ofclaim 1, the remote control device comprising a user interfaceconfigured to provide visual, audio and tactile feedback to a user.
 9. Amethod for controlling a body function of a user comprising: applying aflexible dermis conforming patch to a dermis of the user in proximity toa selected nerve, the patch formed by a substrate and comprisingelectrodes directly coupled to the substrate, electronic circuitryembedded in the patch comprising a system on a chip that is directlycoupled to the substrate and comprising an electrical signal generatorconfigured to electrically activate the electrodes, a signal receiver incommunication with the electric signal generator, an antenna, atransmitter and a receiver; applying an electrical signal generated bythe flexible dermis conforming patch to the selected nerve; and sensingnerve stimulation response; the applying in response to a signal tostart stimulation on the user via the electrodes from a remote controldevice in wireless communication with the electronic circuitry, thesignal generated in response to the user interacting with the remotecontrol device.
 10. The method of claim 9 further comprising monitoringthe nerve response to the electrical signal and adjusting a nervestimulation pattern that is revised in response to the nerve response.11. The method of claim 9 further comprising monitoring a muscleresponse to the nerve stimulation and adjusting a nerve stimulationpattern that is revised in response to the nerve response.
 12. Themethod of claim 9, the remote control device is a smartphone and thesignal is generated via a smartphone app.
 13. The method of claim 9, theremote control device is a key fob controller comprising a button andthe signal is generated via a pressing of the button.
 14. The method ofclaim 9 further comprising applying the flexible dermis conforming patchto the dermis with adhesive.
 15. The method of claim 9 furthercomprising applying more than one flexible dermis conforming patches tothe dermis.
 16. The method of claim 9 further comprising stimulatingmore than one nerve with one or more flexible dermis conforming patchesto create a nerve stimulation pattern.
 17. The method of claim 9 furthercomprising applying the electrical signal to a selected portion of anerve.
 18. The method of claim 9 further comprising selectivelyadjusting a strength of the electrical signal.
 19. The method of claim 9further comprising selectively adjusting a shape of the electricalsignal.
 20. The method of claim 9 further comprising receiving a signalfeedback from a stimulated nerve.
 21. The method of claim 9 furthercomprising receiving feedback from a stimulated nerve and adjusting theelectrical signal based on the feedback.
 22. The method of claim 9, theremote control device comprising a user interface configured to providevisual, audio and tactile feedback to a user.
 23. A topical nervestimulator patch comprising: a substrate; electrodes positioned on thepatch proximal the surface and directly coupled to the substrate;electronic circuitry embedded in the patch comprising a system on a chipthat is directly coupled to the substrate and comprising: an electricalsignal generator configured to electrically activate the electrodes; asignal receiver in communication with the electrical signal generator;an antenna; a transmitter; and a receiver; the electrical circuitryconfigured to be in wireless communication with a remote control device,the remote control device configured to provide a signal to startstimulation on a user via the electrodes, the signal generated inresponse to the user interacting with the remote control device.
 24. Thetopical nerve stimulator patch of claim 23, further comprising afeedback sensor on the patch coupled to the substrate and configured tosense muscle and/or nerve activation and communicate data to the remotecontrol device.
 25. The topical nerve stimulator patch of claim 24, thestimulation based on a stimulation pattern that is revised in responseto the sensed muscle and/or nerve activation.